The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Beautibond.
Device ID | K082744 |
510k Number | K082744 |
Device Name: | BEAUTIBOND |
Classification | Agent, Tooth Bonding, Resin |
Applicant | SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
Contact | David P Morais |
Correspondent | David P Morais SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-09-18 |
Decision Date | 2008-12-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
E23517820 | K082744 | 000 |
E23517810 | K082744 | 000 |
E235IEWK0 | K082744 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BEAUTIBOND 77575762 3667742 Live/Registered |
Shofu, Inc. 2008-09-22 |